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Completed

NCT Number: NCT01913314

A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants

This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered.

In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.

This study will last about 3 weeks for each participant, not including screening.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overtly healthy male or female participants as determined by medical history and physical examination
  • Male participants will be sterile
  • Female participants will be surgically sterile or postmenopausal
  • Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m^2)
  • Have venous access sufficient to allow for blood sampling

Exclusion criteria

  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes

Treatment and study plan

[^14C]-LY2835219

Drug

Administered as oral solution

Other names: abemaciclib

Primary outcomes

  1. Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose

    The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100.

Secondary outcomes

  1. Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  2. Plasma PK of Radioactivity: Cmax

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  3. Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax)

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  4. Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)]

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  5. Plasma PK of Radioactivity: AUC(0 to Tlast)

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

    The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g).

  6. Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)]

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  7. Plasma PK of Radioactivity: AUC(0-∞)

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

  8. Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces

    Time frame: Predose through 216 h postdose; Fecal samples collected at 24-h intervals

    The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.

  9. Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma

    Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose

    The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [^14C]-LY2835219 Following Oral Administration in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 1, 2013
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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